Documentation of the efficacy and tolerability of oxybutynin solution applied directly into the bladder in adult patients with incontinence

Phase 1

• Conditions: Detrusor hyperactivity caused by neurological dysfunction; MedDRA version: 14.1Level: PTClassification code 10061011Term: Bladder disorderSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-011843-38-DE
• Lead Sponsor: Grachtenhaus-Apotheke, Inh. Klaus Stegemann e.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-22
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

- patient´s written informed consent
- patients of both gender aged 18 to 70 years
- patients, who are experienced in the performance of clean (or sterile) intermittent catheterization (CIC) and who perform regularly CIC for at least 6 weeks
- patients with detrusor hyperactivity confirmed by urodynamic measurement within the last 24 months and associated with a known neurological deficit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients under effective and compatible medication
- diseases like polyuria or nycturia due to heart or renal failure, subvesical organic urinary output failure (e. g. prostataadenom, urethral stricture), constrictions (stenosis) in the area of the remaining urinary passage and gastrointestinal tract, acute angle-closure glaucoma (glaucoma) or complanate anterior chamber, fast and abnormal heartbeat (cardiac tachyarrhythmia), severe colon aneurysma (toxic megacolon), severe arteriosclerotic alteration of the celebral vessels (cerebrosclerosis), intestinal obstruction, hiatal hernia with reflux esophagitis, phlogistic colon ulcer, colon atresia
- Myasthenia gravis
- severe hydronephrosis greater than grade 3; a renal ultrasound performed within 3 months prior to entering the study will be accepted as a baseline measurement if this assessment was performed while the patient was on a stable medication regimen
- severe vesical-renal reflux higher than grade 3 according to Parkkulainen based on urodynamic measurement for diagnosis
- symptomatic (febrile) urinary tract infection
- severe limitations in renal function according to laboratory chemical determination of renal function values (Kreatinin > 2,5 mg/dl)
- pathological intraocular pressure – measured within 12 month prior to entering the study
- clinically significant laboratory abnormalities (based on investigator judgment) or laboratory values greater than 2 times the upper limit of standard range
- liver or renal insufficiency
- intake of warfarin, ranitidine or cimetidine
- intake of CYP3A4 inhibiting pharmaceuticals or substances like clomipramine, itraconazole, ketoconazole, testosterone, troleandomycin or CYP2D6 inhibiting pharmaceuticals like dextromethorphan
- intake of anticholinergic or anticholinergic acting pharmaceuticals enhancing the function of oxybutynin, e. g. amantadin and other Anti-Parkinson’s pharmaceuticals, antihistamines, neuroleptics, chinidin, digitalis, trizyclic antidepressants, atropine and related compounds
- intolerance to the active ingredient oxybutynin
- medical history of allergy/hypersensitivity (including drug and sulfa drug allergy) which is deemed as relevant to the trial as judged by the investigator
- treatment with Botulinum Toxin Type A (Botox) injections for urologic use within 6 months of randomization at screening visit
- drug therapy, or non-drug therapy including electrostimulation for their neuropathic bladder initiated during the four weeks prior to screening or anticipated to initiate during the study
- surgical procedure under general anaesthesia within 30 days prior to screening visit
- participation in another trial with an investigational drug within 30 days prior to screening or during the trial
- pregnant or lactating women; all female patients of child bearing potential, who are sexually active in the opinion of the investigator, have to use one accepted and highly effective agent of birth control with a Pearl Index = 1%
- patients who cannot understand the terms of the informed consent form and/or subject information in the investigator's view
- patients who are or have been committed to an institution by virtue of an order either by the judicial or the administrative authorities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified